Population Health Research Institute
Study List

MICHELANGELO/OASIS-5 (Completed)
An International, Randomized, Double-Blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-Segment Elevation MI Acute Coronary Syndromes

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The evaluated whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refractory ischemia up to day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy. Fondaparinux was similar to enoxaparin in reducing the risk of ischemic events but it substantially reduced bleeding an improved long-term mortality and morbidity. The findings the OASIS 5 and 6 trial sled to widespread use, guideline modifications and regulatory approvals for fondaparinux in many countries.

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study.

Intervention: Fondaparinux vs. enoxaparin. 

Length of Study: 4 years

# of Patients: 20,078

Patient Populations: Unstable Angina or Non ST-Segment Elevation, Myocardial Infarction.


Presentations

MICHELANGELO/OASIS-5 Study Results


Main Publications (A full listing of publications can be found in the 'Media & Publictions' section)

Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue, J, Granger CB, Budaj A, Peters RJG, Bassand JP, Wallentin L, Joyner C, Fox KAA for the Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med 2006; 354(14):1464-76. Epub 2006 Mar 14

Mehta SR, Boden WE, Eikelboom JW, Flather M, Steg PG, Avezum A, Afzal R, Piegas LS, Faxon DP, Widimsky P, Budaj A, Chrolavicius S, Rupprecht HJ, Jolly S, Granger CB, Fox KA, Bassand JP, Yusuf S; OASIS 5 and 6 Investigators. Antithrombotic therapy with fondaparinux in relation to interventional management strategy in patients with ST- and non-ST-segment elevation acute coronary syndromes: an individual patient-level combined analysis of the Fifth and Sixth Organization to Assess Strategies in Ischemic Syndromes (OASIS 5 and 6) randomized trials. Circulation. 2008;118(20):2038-46

 

 

 

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